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Pilot Feasibility of Rice Bran Supplementation in Nicaraguan Children

NCT02615886 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2017-07-19

No results posted yet for this study

Summary

The purpose is to assess feasibility of rice bran consumption in weaning children and collect pilot data on gut microbiome and metabolome modulation with rice bran intake for diarrheal prevention.

Conditions

  • Dietary Rice Bran Supplementation

Interventions

OTHER

Observational Control

Participants will be observed and not provided any dietary supplementation.

DIETARY_SUPPLEMENT

Rice bran

Dietary rice bran consumed daily and amounts increase throughout the 6 month intervention (6 months of age: 1 g/day rice bran, 7 months: 2 g/day rice bran, 8 months: 2 g/day, 9 months: 3g/day, 10 months: 4g/day, 11 months: 5g/day).

Sponsors & Collaborators

  • National Autonomous University of Nicaragua

    collaborator OTHER

  • Virginia Polytechnic Institute and State University

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • Colorado State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Months
Max Age
13 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States
  • Nicaragua

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02615886 on ClinicalTrials.gov